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biocept inc (BIOC) Details

Biocept, Inc., a cancer diagnostics company, develops and commercializes proprietary circulating tumor cell (CTC) and circulating tumor DNA tests utilizing a standard blood sample. The company’s tests provide information to oncologists that enable them to select the appropriate treatment for their patients based on detailed data on the characteristics of tumors. It offers OncoCEE-BR, a breast cancer CTC test that allows physician to characterize the tumor to help define treatment options. The company is also developing other OncoCEE CTC tests, including OncoCEE-LU for lung cancer; OncoCEE-GA for gastric cancer; OncoCEE-CR for colorectal cancer; OncoCEE-PR for prostate cancer; and OncoCEE-ME for melanoma. Biocept, Inc. sells its products through its direct sales force and partners that focus on selling directly to community oncologists in hospitals, cancer centers, and offices in the United States, as well as biopharma companies. It has collaboration agreement with Rosetta Genomics, Ltd. to evaluate microRNAs from circulating tumor cells; and Insight Genetics to advance non-small cell lung cancer diagnosis and treatment. The company was founded in 1997 and is headquartered in San Diego, California.

biocept inc (BIOC) Key Developments

Biocept, Inc. announced the launch of ROS1 testing on CTCs, which will help physicians identify which of their patients may be receptive to certain drugs for the treatment of non-small cell lung cancer. Biocept's new blood test identifies chromosomal rearrangements of the gene encoding ROS1 proto-oncogene receptor tyrosine kinase (ROS1), thereby defining a distinct molecular subgroup of NSCLCs. Patients with ROS1-positive tumors may be receptive to a number of therapeutic options that inhibit this target. It can be difficult to obtain enough tissue material for molecular testing of biomarkers like ROS1 from lung cancer patients due to the small size of tissue biopsies. Occasionally, tissue biopsies are altogether impossible because of risks associated with a surgical procedure for these patients. Biocept's 'liquid biopsy' offers a method of determining the crucial genomic status of a tumor using a simple blood test. While Crizotinib is currently only FDA-approved for the treatment of ALK-positive NSCLC patients, National Comprehensive Cancer Network (NCCN) guidelines recommend that patients with advanced lung cancer be considered for ROS1 testing and that Crizotinib should be used to treat patients that test positive for ROS1.

Biocept, Inc. announced the launch of its EGFR mutation test that targets a region of the gene that includes T790M, a biomarker that identifies therapy-resistant tumors utilizing its proprietary Selector technology. This test will be performed at the company's CLIA-certified and CAP-accredited laboratory and is the first of several assays the company will launch based on its proprietary Selector platform. The launch of Selector technology for ctDNA biomarker analysis from plasma in non-small cell lung cancer (NSCLC) expands Biocept's existing test menu of commercialized blood based assays for CTC capture and analysis for breast, gastric and lung cancers. The Selector technology was developed and validated by scientists at Biocept. Approximately 20% of the NSCLC cases diagnosed each year are identified as EGFR-mutant, a correlation which has led to a number of targeted therapies focused on the patient population whose tumor has this mutation. These targeted therapies are known as Tyrosine Kinase Inhibitors, or TKIs. TKIs have been shown to be effective at shrinking tumors for a time, however, many patients ultimately develop resistance to EGFR-targeted TKIs because of secondary mutations such as T790M. Evaluating and monitoring for these secondary mutations in a clinical setting utilizing a blood sample could enhance the way treatment is managed. In addition to better informing clinicians when and how to treat NSCLC with TKIs, there are promising new therapies in clinical testing that target resistance alterations like T790M.

Biocept Is Considering Strategic Alternatives

Jan 9 15

Biocept, Inc. (NasdaqCM:BIOC) may acquire other businesses or form joint ventures or make investments in other companies or technologies that could harm their operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense. As part of their business strategy, they may pursue acquisitions of businesses and assets. Biocept also may pursue strategic alliances and joint ventures that leverage our core technology and industry experience to expand our offerings or distribution. They have no experience with acquiring other companies and limited experience with forming strategic alliances and joint ventures. They may not be able to find suitable partners or acquisition candidates, and may not be able to complete such transactions on favorable terms, if at all. If they make any acquisitions, they may not be able to integrate these acquisitions successfully into our existing business, and could assume unknown or contingent liabilities. Any future acquisitions also could result in significant write-offs or the incurrence of debt and contingent liabilities, any of which could have a material adverse effect on the financial condition, results of operations and cash flows. Integration of an acquired company also may disrupt ongoing operations and require management resources that would otherwise focus on developing our existing business. Biocept may experience losses related to investments in other companies, which could have a material negative effect on the results of operations. They may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at all, and may not realize the anticipated benefits of any acquisition, technology license, strategic alliance or joint venture. To finance any acquisitions or joint ventures, they may choose to issue shares of common stock as consideration, which would dilute the ownership of the stockholders. If the price of the common stock is low or volatile, they may not be able to acquire other companies or fund a joint venture project using our stock as consideration. Alternatively, it may be necessary for them to raise additional funds for acquisitions through public or private financings. Additional funds may not be available on terms that are favorable to them, or at all.

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